Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

CARETEK MEDICAL OBTAINS FUNDING FOR NEEDLE-FREE INJECTIONS

British company Caretek Medical, which is developing an innovative needle-free
drug delivery device, has completed an oversubscribed 2.1 million funding
round in just four weeks.

Pharmaceutical partners looking to combine the novel delivery system with their
own proprietary drugs are already investigating Caretek's patented ImplaJect
device, which is the size of a fountain pen and uses a spring mechanism to deliver
drugs through the skin in a solid dosage form. Caretek will use the new capital
to fund development of the ImplaJect technology through clinical trials of its
first "own brand" product that will combine the device with well-established
generic drugs.

The needle-free ImplaJect device delivers drugs through the skin into the underlying
tissue where the drugs dissolve and are released into the patient's bloodstream.